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United States · US · US:71335-2497_3677e29b-ef5f-459f-a9f0-b74a91b32924
BACLOFEN
Orange BookUNIISPLATC M03BX01
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeM03BX01
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 10
- ndc117133524970120 TABLET in 1 BOTTLE (71335-2497-0)
- ndc11713352497190 TABLET in 1 BOTTLE (71335-2497-1)
- ndc11713352497220 TABLET in 1 BOTTLE (71335-2497-2)
- ndc11713352497360 TABLET in 1 BOTTLE (71335-2497-3)
- ndc11713352497445 TABLET in 1 BOTTLE (71335-2497-4)
- ndc117133524975112 TABLET in 1 BOTTLE (71335-2497-5)
- ndc11713352497630 TABLET in 1 BOTTLE (71335-2497-6)
- ndc11713352497756 TABLET in 1 BOTTLE (71335-2497-7)
- ndc11713352497815 TABLET in 1 BOTTLE (71335-2497-8)
- ndc11713352497984 TABLET in 1 BOTTLE (71335-2497-9)
Annotations
UNII (FDA Substance ID)
H789N3FKE8
BACLOFEN
RxCUI 1292
Orange Book
A214374
ABABAB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "H789N3FKE8",
"rxcui": "1292",
"inchikey": "KPYSYYIEGFHWSV-UHFFFAOYSA-N",
"display_name": "BACLOFEN",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"e017a001-8cb1-4dd8-960e-c6d74005f57f": {
"match": "brand_token",
"title": "BACLOFEN TABLET [REMEDYREPACK INC.]",
"spl_version": "1",
"published_date": "2026-05-13"
}
},
"productid": "71335-2497_3677e29b-ef5f-459f-a9f0-b74a91b32924",
"productndc": "71335-2497",
"dosage_form": "TABLET",
"orange_book": {
"appl_no": "214374",
"products": [
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "5MG",
"product_no": "001",
"approval_date": "Mar 5, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "10MG",
"product_no": "002",
"approval_date": "Mar 5, 2021"
},
{
"rs": false,
"rld": false,
"te_code": "AB",
"strength": "20MG",
"product_no": "003",
"approval_date": "Mar 5, 2021"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BACLOFEN",
"proprietary_name": "BACLOFEN",
"active_ingred_unit": "mg/1",
"application_number": "ANDA214374",
"marketing_category": "ANDA",
"nonproprietary_name": "BACLOFEN",
"start_marketing_date": "20240301",
"active_numerator_strength": "20"
}Related drugs
Other records sharing ATC code M03BX01.
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